ISLAMABAD:Drug Regulatory Authority of Pakistan (DRAP) in collaboration with the World Health Organization (WHO) and the Federal Expanded Programme on Immunization, has arranged a day-long national training for monitoring of adverse event following immunisation (AEFI) of COVID-19 vaccine.
Addressing the session, experts said that the vaccination drive in Pakistan is being carried out through the Expanded Programme on Immunization (EPI) through more than 1500 centres. They said as the vaccines being used globally and have been granted Emergency Use Authorization (EUA) therefore surveillance of any adverse events following immunization is critical.
They said that AEFI surveillance is currently being carried out as a coordinated effort between Federal EPI and Pakistan National Pharmacovigilance Centre (PNPC), DRAP. Dr. Abdur Rasheed, Director, Division of Pharmacy Services and Head, Pakistan National Pharmacovigilance Centre (PNPC) presented about the International Obligation and National Regulatory Requirement for Pharmacovigilance.
He explained the role of each stakeholder such as Pakistan National Pharmacovigilance Centre, Provincial Pharmacovigilance Centre, Public Health Programmes, manufacturers, importers of drugs, vaccines and hospitals as per draft pharmacovigilance rules. This was followed by a presentation from Abdul Mateen, Focal Person Pharmacovigilance and Assistant Director, Pakistan National Pharmacovigilance Centre (PNPC), Drug Regulatory Authority of Pakistan where he presented about VigiFlow database and data entry through it.
The role of the Medical Dictionary for Regulatory Activities (MedDRA) and WHO Drug Dictionary in coding vaccines and drugs and medical terms in the VigiFlow database was also explained.
Hands-on training on data entry in the VigiFlow database was also provided to Provincial EPI and pharmacovigilance Focal Persons during the practical session. Aqsa Hashmi, Assistant Director, Pakistan National Pharmacovigilance Centre (PNPC), Drug Regulatory Authority of Pakistan presented about pharmacovigilance in the context of COVID-19 vaccines. She explained how, when, what and who should carry out the AEFI investigation.
Participants were also briefed about the procedure of causality assessment of AEFI and to strengthen the mechanism of AEFIs Data Entry in VigiFlow System and Case Investigation of Serious AEFIs.